Thalidomide in Treating Patients With Refractory or Resistant Epithelial Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

Phase II Trial of Thalidomide in Patients With Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00016224
• Other study ID #: 01-006
• Secondary ID: CDR0000068611NCI
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2001
• Last updated: June 17, 2013
• Start date: January 2001
• Est. completion date: March 2004

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs such as thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating women who have epithelial ovarian cancer that has not responded to previous therapy.

Description:

OBJECTIVES:

• Determine the time to progression of disease in patients with platinum-refractory or resistant ovarian epithelial carcinoma treated with thalidomide.

• Evaluate the quality of life of patients treated with this regimen.

OUTLINE: Patients receive oral thalidomide once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then every 4 weeks.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 9-15 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian epithelial carcinoma

• Platinum-refractory or resistant disease

• At least 1 prior non-platinum chemotherapy agent required

• Prior bilateral salpingo-oophorectomy and hysterectomy required

• Bidimensionally measurable disease OR CA-125 greater than 100 units/mm3

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• Karnofsky 70-100%

Life expectancy:

• More than 3 months

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin normal

• AST no greater than 2.5 times upper limit of normal (ULN)

Renal:

• Creatinine no greater than 1.5 times ULN OR

• Creatinine clearance at least 50 mL/min

Other:

• No other prior malignancy except non-melanoma skin cancer unless curatively treated with no evidence of disease within the past 5 years and at low risk for recurrence

• No other clinical circumstances that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior biologic therapy and recovered

• No prior thalidomide

Chemotherapy:

• See Disease Characteristics

• At least 4 weeks since prior cytotoxic therapy and recovered

Endocrine therapy:

• At least 4 weeks since prior hormonal therapy and recovered

Radiotherapy:

• At least 4 weeks since prior radiotherapy

Surgery:

• See Disease Characteristics

• At least 4 weeks since prior major surgery

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• thalidomide

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,